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Epithelial ovarian cancer
Section
7: Clinical trials

Randomised clinical trials provide the strongest evidence on the efficacy
of surgical and chemotherapy treatments for ovarian cancer. Despite their value,
recruitment to trials is often limited with only a small proportion of ovarian
cancer patients receiving treatment as part of a clinical trial.

A systematic review and an observational study exploring barriers to participation
in clinical trials in the UK were identified.136,
137
The systematic review found that patients who are more knowledgeable about
the randomisation process are less likely to participate in trials.137
This suggests that participation in trials might be improved by increasing
awareness about the other benefits of being involved in a trial in addition
to the possibility
of receiving the experimental treatment. Evidence level 1++,3

The observational study explored recruitment to an individual trial in the
UK and found that most people considered for trial inclusion did not meet
inclusion
criteria.136
Participation by people eligible for the study was high as long as their physician
decided that they should be considered for the study. This study indicated
that
patient selection may result in different outcomes between participants and
non-participants, specifically, older and more severely ill patients were
less
likely to be entered into trials, possibly causing better outcomes to be observed
for trial patients. Evidence level 3

A systematic review of 14 studies was identified that looked at whether participation
in RCTs is beneficial or harmful for patients.138
The review included cancer treatment studies but was not exclusively limited
to them. The study considered different possible sources of effect and bias.
Eight of the studies included in the review showed a statistically significant
positive effect from trial participation, and six did not. No studies showed
a negative outcome. The review concluded that a positive effect was more likely
when a trial compared a known effective treatment with a new treatment. The
review also concluded that it is not possible to separate protocol effect from
possible bias due to clinician selection.138Evidence
level 2++

Clinical trials should have appropriate inclusion criteria and
should incorporate recognised standard treatment.